MAUDE Adverse Event Report: ABBOTT VASCULAR SUPERA SELF-EXPANDING STENT SYSTEM; SELF EXPANDING PERIPHERAL STENT SYSTEM

Model Number S-60-080-120-P6

Device Problems Patient-Device Incompatibility (2682); Migration (4003)

Patient Problem Embolism/Embolus (4438)

Event Date 03/23/2023

Event Type  Injury  

Manufacturer Narrative

D4: the unique device identifier (udi) is unknown because the part number and lot number were not provided.Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Event Description

Patient id: (b)(6).It was reported that on (b)(6)2022 a supera stent was implanted in the distal popliteal artery to the tibioperoneal trunk.At some point post stent implantation, ultrasound noted an occlusion in the posterior tibial artery.On (b)(6)2023, angiography was performed and noted that the supera stent had migrated.Attempts were made to pass a wire through the migrated stent, but attempts were unsuccessful.It was decided that since there was brisk in-line flow through the anterior tibial artery (ata) and since the patient's wounds were healing, no revascularization intervention in the pta would be performed.No additional information was provided.

Event Description

Subsequent to the initial medwatch report, the following information was received: it was reported that at the time of deployment, the supera stent was thought to be well apposed to the vessel wall, but since the stent migrated, the cause of the migration may possibly be due to stent under-sizing that was not noted at the time of implantation.Additionally, it is unlikely that the supera stent, which migrated from the site of implantation (distal popliteal to tibioperoneal trunk) to the anterior tibial artery (ata) caused or contributed to the lower limb arterial occlusion as there was brisk arterial flow noted through the ata.The occlusion was noted in the posterior tibial artery (pta) due to progression of disease and restenosis in the area.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents from this lot.The reported patient effect of embolism is listed in the supera peripheral stent system instructions for use instructions for use (ifu) as a potential adverse event.It is possible that during initial deployment the diameter of the stent used was inadvertently undersized for the size of the vessel; thus resulting in the reported patient-device incompatibility wall apposition and ultimately resulted in the reported stent migration; however this cannot be confirmed.The investigation determined a conclusive cause for the reported difficulties cannot be determined.Additionally, the reported difficulties possibly contributed to the reported patient effect; however a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.However, the treatments appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: SUPERA SELF-EXPANDING STENT SYSTEM
• Type of Device: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 16942521
• MDR Text Key: 315334697
• Report Number: 2024168-2023-05228
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648211812
• UDI-Public: 08717648211812
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: S-60-080-120-P6
• Device Catalogue Number: S-60-080-120-P6
• Device Lot Number: 2020361
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/28/2023
• Initial Date FDA Received: 05/16/2023
• Supplement Dates Manufacturer Received: 05/17/2023
• Supplement Dates FDA Received: 05/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 89 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White